Approval Order Statement
APPROVAL FOR THE CLARION MULTI-STRATEGY COCHLEAR IMPLANT. THE DEVICE IS INTENDED TO RESTORE A LEVEL OF AUDITORY SENSATION TO CHILDREN WITH PROFOUND SENSORINEURAL DEAFNESS VIA ELECTRICAL STIMULATION OF THE AUDITORY NERVE. CLARION IS INDICATED FOR THE FOLLOWING: 1)CHILDREN, 2 THROUGH 17 YEARS OF AGE. IF X-RAYS DEMONSTRATE EVIDENCE OF OSSIFICATION, CHILDREN AS YOUNG AS 18 MONTHS MAY BE IMPLANTED; 2)PROFOUND, BILATERAL SENSORINEURAL DEAFNESS; 3)UNDERGONE OR BE WILLING TO UNDERGO A HEARING AID TRAIL WITH APPROPRIATELY FITTED HEARING AIDS; 4)LACK OF BENEFIT FROM APPROPRIATELY FITTING HEARING AIDS. IN YOUNGER CHILDREN, LACK OF BENEFIT WITH HEARING AIDS IS DEFINED AS FAILURE TO ATTAIN BASIC AUDITORY MILESTONES SUCH AS A CHILD'S INCONSISTENT RESPONSE TO HIS/HER NAME IN QUIET OR TO ENVIRONMENTAL SOUNDS (MEANINGFUL AUDITORY INTEGRATION SCALE). IN OLDER CHILDREN, LACK OF AIDED BENEFIT IS DEFINED AS SCORING 0% ON OPEN-SET WORD RECOGNITION (PHONETICALLY BALANCED KINDERGARTEN TEST - WORD LIST) ADMINISTERED WITH MONITORED LIVE-VOICE (70 DB SPL). BOTH YOUNGER AND OLDER CHILDREN SHOULD DEMONSTRATE ONLY MINIMAL ABILITY ON AGE APPROPRIATE OPEN-SET SENTENCE MEASURES AND A PLATEAU IN AUDITORY DEVELOPMENT. |
